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  1. AU="Daniel Freilich"
  2. AU="Glascock, Abigail L"
  3. AU="Gordon Bernard"
  4. AU="Lv, Mengwen"
  5. AU="Rottman Pietrzak, Kathleen A"
  6. AU=Panczak Radoslaw
  7. AU="Hosseini, Seyed Mohammad Hadi"
  8. AU="Noda, Haruna"
  9. AU="Raoul, Cédric"
  10. AU=Wissing Silke AU=Wissing Silke
  11. AU="Chun-Lin Yang"
  12. AU="Romine, Kyle A"
  13. AU="Cunsolo, Vincenzo"
  14. AU="Ba, Aboubacar"
  15. AU="Prisca, Mirandolina"
  16. AU="Perez, Tate"
  17. AU="Bakkaloglu, Sevan"
  18. AU="Guernieri, Rebecca L"
  19. AU="Xing, Z Y"
  20. AU="Yu-Heng Cheng"
  21. AU=Freeman Richard B Jr
  22. AU="Wang, Qi-En"
  23. AU="Mallamaci, M"
  24. AU="Turk, Yael R"
  25. AU="Tinto, Monica"
  26. AU="Selvendiran, Karuppaiyah" AU="Selvendiran, Karuppaiyah"
  27. AU="Enns, Murray W"
  28. AU="Yaohua Yang" AU="Yaohua Yang"

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  1. Artikel ; Online: COVIDMED – An early pandemic randomized clinical trial of losartan treatment for hospitalized COVID-19 patients

    Daniel Freilich / Jennifer Victory / Paul Jenkins / Anne Gadomski

    Contemporary Clinical Trials Communications, Vol 29, Iss , Pp 100968- (2022)

    2022  

    Abstract: Objectives: To assess the efficacy and safety of losartan for COVID-19 patients. Methods: COVIDMED was a double-blinded, placebo-controlled platform RCT. Enrollees were randomized to standard care plus hydroxychloroquine, lopinavir/ritonavir, losartan, ... ...

    Abstract Objectives: To assess the efficacy and safety of losartan for COVID-19 patients. Methods: COVIDMED was a double-blinded, placebo-controlled platform RCT. Enrollees were randomized to standard care plus hydroxychloroquine, lopinavir/ritonavir, losartan, or placebo. Hydroxychloroquine and lopinavir/ritonavir arms were discontinued early. We report losartan data vs. combined (lopinavir-ritonavir and placebo) and prespecified placebo-only controls. The primary endpoint was the mean COVID-19 Ordinal Severity Score (COSS) slope of change. Slow enrollment prompted early termination. Results: Fourteen patients were included in our final analysis (losartan [N = 9] vs. control [N = 5] [lopinavir/ritonavir [N = 2], placebo [N = 3]]). Most baseline parameters were balanced. Losartan treatment was not associated with a difference in mean COSS slope of change vs. combined (p = 0.4) or placebo-only control (p = 0.05) (trend favoring placebo). 60-day mortality and overall AE/SAE rates were insignificantly higher with losartan. Conclusion: In this small RCT in hospitalized COVID-19 patients, losartan did not improve outcome and was associated with adverse safety signals.
    Schlagwörter Losartan ; Angiotensin converting enzyme inhibitor (ACEi) ; Angiotensin II receptor Blocker (ARB) ; COVID-19 ; SARS-CoV-2 ; Randomized clinical trial (RCT) ; Medicine (General) ; R5-920
    Thema/Rubrik (Code) 610
    Sprache Englisch
    Erscheinungsdatum 2022-10-01T00:00:00Z
    Verlag Elsevier
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  2. Artikel ; Online: Hydroxychloroquine/chloroquine for the treatment of hospitalized patients with COVID-19

    Leon Di Stefano / Elizabeth L Ogburn / Malathi Ram / Daniel O Scharfstein / Tianjing Li / Preeti Khanal / Sheriza N Baksh / Nichol McBee / Joshua Gruber / Marianne R Gildea / Megan R Clark / Neil A Goldenberg / Yussef Bennani / Samuel M Brown / Whitney R Buckel / Meredith E Clement / Mark J Mulligan / Jane A O'Halloran / Adriana M Rauseo /
    Wesley H Self / Matthew W Semler / Todd Seto / Jason E Stout / Robert J Ulrich / Jennifer Victory / Barbara E Bierer / Daniel F Hanley / Daniel Freilich / Pandemic Response COVID-19 Research Collaboration Platform for HCQ/CQ Pooled Analyses

    PLoS ONE, Vol 17, Iss 9, p e

    An individual participant data meta-analysis.

    2022  Band 0273526

    Abstract: Background Results from observational studies and randomized clinical trials (RCTs) have led to the consensus that hydroxychloroquine (HCQ) and chloroquine (CQ) are not effective for COVID-19 prevention or treatment. Pooling individual participant data, ... ...

    Abstract Background Results from observational studies and randomized clinical trials (RCTs) have led to the consensus that hydroxychloroquine (HCQ) and chloroquine (CQ) are not effective for COVID-19 prevention or treatment. Pooling individual participant data, including unanalyzed data from trials terminated early, enables more detailed investigation of the efficacy and safety of HCQ/CQ among subgroups of hospitalized patients. Methods We searched ClinicalTrials.gov in May and June 2020 for US-based RCTs evaluating HCQ/CQ in hospitalized COVID-19 patients in which the outcomes defined in this study were recorded or could be extrapolated. The primary outcome was a 7-point ordinal scale measured between day 28 and 35 post enrollment; comparisons used proportional odds ratios. Harmonized de-identified data were collected via a common template spreadsheet sent to each principal investigator. The data were analyzed by fitting a prespecified Bayesian ordinal regression model and standardizing the resulting predictions. Results Eight of 19 trials met eligibility criteria and agreed to participate. Patient-level data were available from 770 participants (412 HCQ/CQ vs 358 control). Baseline characteristics were similar between groups. We did not find evidence of a difference in COVID-19 ordinal scores between days 28 and 35 post-enrollment in the pooled patient population (odds ratio, 0.97; 95% credible interval, 0.76-1.24; higher favors HCQ/CQ), and found no convincing evidence of meaningful treatment effect heterogeneity among prespecified subgroups. Adverse event and serious adverse event rates were numerically higher with HCQ/CQ vs control (0.39 vs 0.29 and 0.13 vs 0.09 per patient, respectively). Conclusions The findings of this individual participant data meta-analysis reinforce those of individual RCTs that HCQ/CQ is not efficacious for treatment of COVID-19 in hospitalized patients.
    Schlagwörter Medicine ; R ; Science ; Q
    Thema/Rubrik (Code) 310
    Sprache Englisch
    Erscheinungsdatum 2022-01-01T00:00:00Z
    Verlag Public Library of Science (PLoS)
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  3. Artikel ; Online: Toward a surrogate marker of malaria exposure

    Joseph J Campo / Timothy J Whitman / Daniel Freilich / Timothy H Burgess / Gregory J Martin / Denise L Doolan

    PLoS ONE, Vol 6, Iss 7, p e

    modeling longitudinal antibody measurements under outbreak conditions.

    2011  Band 21826

    Abstract: Background Biomarkers of exposure to Plasmodium falciparum would be a useful tool for the assessment of malaria burden and analysis of intervention and epidemiological studies. Antibodies to pre-erythrocytic antigens represent potential surrogates of ... ...

    Abstract Background Biomarkers of exposure to Plasmodium falciparum would be a useful tool for the assessment of malaria burden and analysis of intervention and epidemiological studies. Antibodies to pre-erythrocytic antigens represent potential surrogates of exposure. Methods and findings In an outbreak cohort of U.S. Marines deployed to Liberia, we modeled pre- and post-deployment IgG against P. falciparum sporozoites by immunofluorescence antibody test, and both IgG and IgM against the P. falciparum circumsporozoite protein by enzyme-linked immunosorbant assay. Modeling seroconversion thresholds by a fixed ratio, linear regression or nonlinear regression produced sensitivity for identification of exposed U.S. Marines between 58-70% and specificities between 87-97%, compared with malaria-naïve U.S. volunteers. Exposure was predicted in 30-45% of the cohort. Conclusion Each of the three models tested has merits in different studies, but further development and validation in endemic populations is required. Overall, these models provide support for an antibody-based surrogate marker of exposure to malaria.
    Schlagwörter Medicine ; R ; Science ; Q
    Sprache Englisch
    Erscheinungsdatum 2011-01-01T00:00:00Z
    Verlag Public Library of Science (PLoS)
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  4. Artikel ; Online: Use of recombinant factor VIIa (rFVIIa) as pre-hospital treatment in a swine model of fluid percussion traumatic brain injury

    Bobby Kim / Ashraful Haque / Françoise G Arnaud / Kohsuke Teranishi / Thomas Steinbach / Charles R Auker / Richard M McCarron / Daniel Freilich / Anke H Scultetus

    Journal of Emergencies, Trauma and Shock, Vol 7, Iss 2, Pp 102-

    2014  Band 111

    Abstract: Context: Recombinant factor VIIa (rFVIIa) has been used as an adjunctive therapy for acute post-traumatic hemorrhage and reversal of iatrogenic coagulopathy in trauma patients in the hospital setting. However, investigations regarding its potential use ... ...

    Abstract Context: Recombinant factor VIIa (rFVIIa) has been used as an adjunctive therapy for acute post-traumatic hemorrhage and reversal of iatrogenic coagulopathy in trauma patients in the hospital setting. However, investigations regarding its potential use in pre-hospital management of traumatic brain injury (TBI) have not been conducted extensively. Aims: In the present study, we investigated the physiology, hematology and histology effects of a single pre-hospital bolus injection of rFVIIa compared to current clinical practice of no pre-hospital intervention in a swine model of moderate fluid percussion TBI. Materials and Methods: Animals were randomized to receive either a bolus of rFVIIa (90 μg/kg) or nothing 15 minutes (T15) post-injury. Hospital arrival was simulated at T60, and animals were euthanized at experimental endpoint (T360). Results: Survival was 100% in both groups; baseline physiology parameters were similar, vital signs were comparable. Animals that received rFVIIa demonstrated less hemorrhage in subarachnoid space (P = 0.0037) and less neuronal degeneration in left hippocampus, pons, and cerebellum (P = 0.00009, P = 0.00008, and P = 0.251, respectively). Immunohistochemical staining of brain sections showed less overall loss of microtubule-associated protein 2 (MAP2) and less Flouro-Jade B positive cells in rFVIIa-treated animals. Conclusions: Early pre-hospital administration of rFVIIa in this swine TBI model reduced neuronal necrosis and intracranial hemorrhage (ICH). These results merit further investigation of this approach in pre-hospital trauma care.
    Schlagwörter Coagulopathy ; necrosis ; pre-hospital ; rFVIIa ; swine ; traumatic brain injury ; Medical emergencies. Critical care. Intensive care. First aid ; RC86-88.9 ; Internal medicine ; RC31-1245 ; Medicine ; R
    Sprache Englisch
    Erscheinungsdatum 2014-01-01T00:00:00Z
    Verlag Medknow Publications
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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